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NCT03899155ClinicalTrials.gov

Pan Tumor Rollover Study

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

المرحلة 2مطلوب 1,500 مشارك399 موقعاً38 دولة

الفئات

علم الأورام100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2019-04-02; recorded start 2019-08-09
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 321 other studies in this databaseCounted from the lead sponsor named in the record (Bristol-Myers Squibb)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Non-randomised allocation

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 399 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,500 participants (target), run at 399 sites, across 38 countries.

How this score is built
  • Enrolment32/40

    1,500 participants (target)

  • Site count25/25

    399 sites

  • Country count15/15

    38 countries

  • Planned duration10/10

    Planned over about 122 months

  • Sponsor scale9/10

    Bristol-Myers Squibb has led 310 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

الحالات

  • Cancer

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Inclusion Criteria * Signed Written Informed Consent. * Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study. * On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study. * WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF. Exclusion Criteria * Participant is not eligible for study treatment per the Parent Study eligibility criteria. * Participants not receiving clinical benefit as assessed by the Investigator. * Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant. * Other protocol-defined Inclusion/Exclusion Criteria apply

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 2
التخصيصغير معشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 1,500 مشارك

الجهة الراعية والمتعاونون

  • Bristol-Myers Squibb الجهة الراعية
  • Exelixis المتعاونون
  • Novartis المتعاونون
  • Clovis Oncology, Inc. المتعاونون
  • Janssen Pharmaceuticals المتعاونون

الأذرع والتدخلات

  • E10: Pemetrexed MonotherapyEXPERIMENTAL
  • E11: Pembrolizumab MonotherapyEXPERIMENTAL
  • E3: Leucovorin + FluorouracilEXPERIMENTAL
  • E6: Sunitinib MonotherapyEXPERIMENTAL
  • E7: Rucaparib MonotherapyEXPERIMENTAL
  • E8: Capecitabine MonotherapyEXPERIMENTAL
  • E9: Cabozantinib MonotherapyEXPERIMENTAL
  • A1: Nivolumab Monotherapy Dose 1EXPERIMENTAL
  • A2: Nivolumab Monotherapy Dose 2EXPERIMENTAL
  • B1: Nivolumab + IpilimumabEXPERIMENTAL
  • B2: Nivolumab + Ipilimumab + CabozantinibEXPERIMENTAL
  • B3: Nivolumab + Ipilimumab + TrametinibEXPERIMENTAL
  • C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1EXPERIMENTAL
  • C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2EXPERIMENTAL
  • C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1EXPERIMENTAL
  • C4: Relatlimab + Nivolumab SAV Dose 2EXPERIMENTAL
  • C5: Relatlimab + Nivolumab + IpilimumabEXPERIMENTAL
  • C6: Relatlimab + Nivolumab + CapecitabineEXPERIMENTAL
  • C7: Relatlimab + Nivolumab SAV Dose 3EXPERIMENTAL
  • C10: Relatlimab + Nivolumab SAV Dose 4EXPERIMENTAL
  • C12: Relatlimab + Nivolumab SAV Dose 5EXPERIMENTAL
  • C8: Relatlimab + Nivolumab SAV + PDCT Dose 1EXPERIMENTAL
  • C9: Relatlimab + Nivolumab SAV + BevacizumabEXPERIMENTAL
  • C11: Relatlimab + Nivolumab SAV + PDCT Dose 2EXPERIMENTAL
  • D1: Nivolumab + TemozolomideEXPERIMENTAL
  • D2: Nivolumab + RucaparibEXPERIMENTAL
  • D3: Nivolumab + DaratumumabEXPERIMENTAL
  • D4: Nivolumab + BevacizumabEXPERIMENTAL
  • E1: Bevacizumab MonotherapyEXPERIMENTAL
  • E2: Regorafinib MonotherapyEXPERIMENTAL
  • E4: Leucovorin + Oxaliplatin + FluorouracilEXPERIMENTAL
  • E5: Enzalutamide MonotherapyEXPERIMENTAL

التدخلات

  • دواء Bevacizumab

    Specified dose on specified days

  • دواء Cabozantinib

    Specified dose on specified days

  • دواء Capecitabine

    Specified dose on specified days

  • دواء Daratumumab

    Specified dose on specified days

  • دواء Enzalutamide

    Specified dose on specified days

  • دواء Fluorouracil

    Specified dose on specified days

  • دواء Ipilimumab

    Specified dose on specified days

  • دواء Leucovorin

    Specified dose on specified days

  • دواء Nivolumab

    Specified dose on specified days

  • دواء Nivolumab + Relatlimab

    Specified dose on specified days

  • دواء Oxaliplatin

    Specified dose on specified days

  • دواء Pembrolizumab

    Specified dose on specified days

  • دواء Pemetrexed

    Specified dose on specified days

  • دواء Regorafinib

    Specified dose on specified days

  • دواء Relatlimab

    Specified dose on specified days

  • دواء Rucaparib

    Specified dose on specified days

  • دواء Sunitinib

    Specified dose on specified days

  • دواء Temozolomide

    Specified dose on specified days

  • دواء Trametinib

    Specified dose on specified days

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Incidence of Adverse Events (AEs)

    الإطار الزمني From Day 1 up to 135 Days after discontinuation of treatment

  2. مقياس النتيجة الأولي

    Incidence of drug related AEs

    الإطار الزمني From Day 1 up to 135 Days after discontinuation of treatment

  3. مقياس النتيجة الأولي

    Incidence of AEs leading to Discontinuation

    الإطار الزمني From Day 1 up to 135 Days after discontinuation of treatment

  4. مقياس النتيجة الأولي

    Incidence of Serious Adverse Events (SAEs)

    الإطار الزمني From signature of Informed Consent up to 135 Days after discontinuation of treatment

  5. مقياس النتيجة الأولي

    Incidence of Select AEs

    الإطار الزمني From Day 1 up to 135 Days after discontinuation of treatment

  6. مقياس النتيجة الأولي

    Incidence of Immune-Mediated AEs

    الإطار الزمني From Day 1 up to 135 Days after discontinuation of treatment

  7. مقياس النتيجة الأولي

    Incidence of Death

    الإطار الزمني From signature of Informed Consent up to 135 Days after discontinuation of treatment

التواريخ

تاريخ البدء9 أغسطس 2019 (فعلي)
الإتمام الأولي25 أغسطس 2029 (تقديري)
الإتمام25 أغسطس 2029 (تقديري)
أول نشر2 أبريل 2019 (فعلي)
آخر تحديث29 يوليو 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

109 مواقع قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Local Institution - 0199BerazateguiBuenos Airesمكتمل
Local Institution - 0201Buenos Airesمسحوب
Instituto FlemingBuenos Airesقيد التجنيد
Local InstitutionCABAمسحوب
Local Institution - 0170Córdobaمسحوب
Fundacion Richardet Longo - IONCCórdobaقيد التجنيد
Sanatorio ParqueRosarioSanta Fe Provinceقيد التجنيد
Instituto Medico Rio CuartoRío CuartoCórdoba Provinceقيد التجنيد
Local Institution - 0191San Miguel de TucumánTucumán Provinceمكتمل
CAIPO Centro para la Atencion Integral del Paciente OncologicoSan Miguel de TucumánTucumán Provinceقيد التجنيد
Centro de Investigaciones Clinicas. Clinica Viedma S.A.ViedmaRío Negro Provinceقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Local InstitutionAdelaideSouth Australiaمسحوب
BRICC - Ballarat Health ServicesBallaratVictoriaقيد التجنيد
Local Institution - 0045Coffs HarbourNew South Walesمكتمل
Local Institution - 0196Elizabeth ValeSouth Australiaمكتمل
Local Institution - 0365FitzroyVictoriaمكتمل
Local Institution - 0372GreenslopesQueenslandمسحوب
Gallipoli Medical FoundationGreenslopesQueenslandقيد التجنيد
Cabrini Hospital MalvernMalvernVictoriaقيد التجنيد
Local Institution - 0174MurdochWestern Australiaمسحوب
Melanoma Institute AustraliaNorth SydneyNew South Walesقيد التجنيد
Local InstitutionSouth BrisbaneQueenslandمسحوب
Tasman Oncology Research LtdSouthportQueenslandقيد التجنيد
Local Institution - 0009SydneyNew South Walesمكتمل
Local Institution - 0193WaratahNew South Walesمكتمل
Local Institution - 0208WestmeadNew South Walesمكتمل

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Local Institution - 0254GrazStyriaمكتمل
Ordensklinikum Linz GmbH ElisabethinenLinzUpper Austriaقيد التجنيد
Local Institution - 0321Viennaمكتمل
Local Institution - 0104Viennaمكتمل
Local Institution - 0145Welsمكتمل

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Local Institution - 0329Brusselsمسحوب
Local Institution - 0232Ghentمكتمل
Local Institution - 0139Jetteمكتمل
Local Institution - 0261Liègeمسحوب
Local Institution - 0293Sint-Niklaasمسحوب
Local Institution - 0157Yvoirمكتمل

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Local Institution - 0264BarretosSão Pauloمكتمل
Local Institution - 0260Belo HorizonteMinas Geraisمكتمل
ONCOSITE - Centro de Pesquisa Clinica em OncologiaIjuíRio Grande do Sulقيد التجنيد
Local Institution - 0379Passo FundoRio Grande do Sulمسحوب
Local Institution - 0093Porto AlegreRio Grande do Sulلم يبدأ التجنيد بعد
Irmandade da Santa Casa de Misericordia de Porto AlegrePorto AlegreRio Grande do Sulقيد التجنيد
Hospital Sao Lucas Da PucrsPorto AlegreRio Grande do Sulقيد التجنيد
Local Institution - 0399Porto AlegreRio Grande do Sulمسحوب
Local Institution - 0258Rio de Janeiroمكتمل
Local Institution - 0266Rio de Janeiroمكتمل
Local Institution - 0262São José do Rio PretoSão Pauloمكتمل
Local Institution - 0355São PauloSão Pauloمكتمل
Local Institution - 0263São PauloSão Pauloمسحوب

يُدرَج 349 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT03899155